Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000254594
Ethics application status
Approved
Date submitted
12/01/2024
Date registered
14/03/2024
Date last updated
14/07/2024
Date data sharing statement initially provided
14/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the role of Immersive Virtual Reality mindfulness in mitigating acute exercise-induced pain following exercise in chronic low back pain: a feasibility randomized controlled trial
Scientific title
Evaluating the role of Immersive Virtual Reality mindfulness in mitigating acute exercise-induced pain following exercise in chronic low back pain: a feasibility randomized controlled trial
Secondary ID [1] 311310 0
NIL known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 332562 0
Condition category
Condition code
Musculoskeletal 329262 329262 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will take place immediately following completion of the routinely physical exercise class. The routinely physical exercise class is part of a conservative management for patients referred for surgical considerations of their low back pain. The exercise class is conducted in a gym setting with up to 8 individuals. Attendees are provided with an individualised program that may include a combination of strength, mobility, movement control, and/or cardiovascular fitness. Individuals are generally referred to once weekly sessions for six weeks, with each session lasting 45-60 minutes. For the intervention, participants undertaking virtual reality mindfulness (VRM) will be familiarized with the virtual reality headset, before undertaking a single, 10-15-minute mindfulness/meditation intervention. We will use the Guided Meditation VR (Meta) as the virtual reality software application. The use of virtual reality headset and chosen software application allows for an immersive setting in a calm and naturalistic environment with an oral guided mindfulness session. As part of the intervention, individuals will be guided through a series of mindfulness/meditation exercises, including breathing exercisers, body scans, and acceptance of emotions and thoughts. The participants will be asked to follow the guided mindfulness instructions. Participants can elect to complete the VRM in either a seated or supine position. The intervention will consist of a single session following their routinely physical exercise class. The intervention will be administered by a qualified member of the research staff. Adherence will be monitored by direct supervision by the administering research staff.
Intervention code [1] 327760 0
Treatment: Devices
Comparator / control treatment
Usual post-exercise management (i.e., no specific intervention) where attendees are instructed to monitor their symptoms following the exercise session, and to contact the treating physiotherapist if they experience a significant exacerbation of their symptoms.
Control group
Active

Outcomes
Primary outcome [1] 337083 0
Current pain level
Timepoint [1] 337083 0
Average pain level (over the preceding 7 days) and current pain level will be measured immediately pre-exercised class.
Current pain levels will be measured post completion of exercise class.
Current pain levels will be measured at 15 min, 1-hour, 3-hour, 6/24-hour, 2-, 3-, and 4-days post-completion of mindfulness intervention.
Secondary outcome [1] 430606 0
Feasibility of the intervention
Timepoint [1] 430606 0
Upon conclusion of the study (4-days post-completion of mindfulness intervention following completion of data collection).
Secondary outcome [2] 430607 0
Acceptability of the intervention
Timepoint [2] 430607 0
Will be administered immediately following completion of mindfulness intervention.
Secondary outcome [3] 431658 0
Feasibility of the intervention
Timepoint [3] 431658 0
Upon conclusion of the study (4-days post-completion of mindfulness intervention following completion of data collection).
Secondary outcome [4] 431660 0
Feasibility of the intervention
Timepoint [4] 431660 0
Upon conclusion of the study (4-days post-completion of mindfulness intervention following completion of data collection).
Secondary outcome [5] 431663 0
Simulator Sickness
Timepoint [5] 431663 0
Will be administered immediately following the intervention

Eligibility
Key inclusion criteria
Individuals will be eligible if they have had low back pain for a minimum of 3 months, access to a mobile phone for SMS, a minimum of 3 on an 11-point numeric scale, at least moderate chronic low back pain related disability, and currently part of clinic-based physiotherapy exercise program for their chronic low back pain.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for the participants includes severe vertigo, severe susceptibility to motion sickness, current use of VRM, visually impaired to the degree they can’t use the VRM as intended, pregnancy, back pain of a non-musculoskeletal cause, severe neurological deficit, or symptoms (e.g., cauda equina syndrome, myelopathy, or evidence of nerve root compromise), use of medical analgesics, or insufficient understanding of English and inability to follow directions and instructions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation. . The block randomization procedure will be to allocate participants to blocks with a block size of 4 with 6 different allocations combinations with 2 control and 2 treatments
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/07/2024
Actual
Date of last participant enrolment
Anticipated
12/08/2024
Actual
Date of last data collection
Anticipated
16/08/2024
Actual
Sample size
Target
48
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26791 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 26792 0
North Lakes Health Precinct - North Lakes
Recruitment postcode(s) [1] 42841 0
4029 - Herston
Recruitment postcode(s) [2] 42842 0
4509 - North Lakes

Funding & Sponsors
Funding source category [1] 315564 0
University
Name [1] 315564 0
University of Queensland - RECOVER Research and Injury Centre
Country [1] 315564 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Block 20 Royal Brisbane and Women’s Hospital, Butter??eld St, Herston QLD 4006
Country
Australia
Secondary sponsor category [1] 317658 0
None
Name [1] 317658 0
Address [1] 317658 0
Country [1] 317658 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314464 0
Metro North Health Human Research Ethics Committee B
Ethics committee address [1] 314464 0
[email protected]
Ethics committee country [1] 314464 0
Australia
Date submitted for ethics approval [1] 314464 0
29/11/2023
Approval date [1] 314464 0
06/02/2024
Ethics approval number [1] 314464 0
104407 Approval

Summary
Brief summary
Management of chronic low back pain is challenging, and current best evidence recommends incorporating physiotherapeutic exercise training. Despite this, physical exercise can lead to flare up in pain immediately following exercise and over the subsequent days in individuals with chronic pain. Virtual reality (VR) is a novel emerging technology that is increasingly being used in pain rehabilitation with demonstrated effectiveness in decreasing pain. One application of VR that has received relatively little attention to date in the management of chronic pain is virtual reality mindfulness/meditation (VRM). VRM offers a novel approach to addressing chronic pain as it can create a calming and relaxing setting that facilitates practicing mindfulness skills, with demonstrated effects. This study investigates if VRM has a positive effect on reducing exacerbation of pain following exercise among individuals with chronic low back pain. We hypothesise that the VRM intervention will reduce immediate and laten pain levels compared to controls undertaking usual post-exercise management as well as the VRM is tolerated with minimal side effects and is feasible and acceptable.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131670 0
Prof Trevor Russell
Address 131670 0
RECOVER INJURY RESEARCH CENTRE, 296 Herston Rd, Herston QLD 4029
Country 131670 0
Australia
Phone 131670 0
+61 7 3365 5560
Fax 131670 0
Email 131670 0
[email protected]
Contact person for public queries
Name 131671 0
Trevor Russell
Address 131671 0
RECOVER INJURY RESEARCH CENTRE, 296 Herston Rd, Herston QLD 4029
Country 131671 0
Australia
Phone 131671 0
+61 7 3365 5560
Fax 131671 0
Email 131671 0
[email protected]
Contact person for scientific queries
Name 131672 0
Trevor Russell
Address 131672 0
RECOVER INJURY RESEARCH CENTRE, 296 Herston Rd, Herston QLD 4029
Country 131672 0
Australia
Phone 131672 0
+61 7 3365 5560
Fax 131672 0
Email 131672 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.